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Carpal Tunnel SyndromePhase 2NCT03111186

Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

A Phase 2 study testing Oxycodone Hcl 5Mg, Ibuprofen 400 mg and Acetaminophen 650 mg in people with Carpal Tunnel Syndrome and Dupuytren Contracture, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is about pain control and medication following outpatient soft-tissue hand surgery. We hope to learn if ibuprofen and acetaminophen will achieve similar pain relief and satisfaction when compared with oxycodone alone. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oxycodone Hcl 5Mg, Ibuprofen 400 mg and Acetaminophen 650 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
24 Apr 2017to 1 May 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age greater than 18 years
  • scheduled to undergo elective outpatient soft tissue hand surgery for one of the following procedures: Carpal tunnel release, Dupuytren contracture release, trigger digit release, ganglion cyst removal, de Quervain's release.
  • primary language is English or Spanish

Who cannot join

  • any pre-existing condition requiring preoperative opiate analgesia, eg chronic pain syndrome
  • allergy to acetaminophen, ibuprofen, or oxycodone
  • renal impairment or liver disease either documented based on history or when preoperative creatinine, BUN, or liver function tests are outside the normal range provided by the lab
  • peptic ulcer disease or any history of gastrointestinal bleeding
  • coagulopathy documented on history, review of systems, or based on preoperative lab testing where PT, PTT, or INR are outside the normal range provided by the lab
  • pregnancy based on positive beta-HCG test which is performed on the day of the surgical procedure as is standard protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Keck School of Medicine of the University of Southern California

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery

This study is about pain control and medication following outpatient soft-tissue hand surgery. We hope to learn if ibuprofen and acetaminophen will achieve similar pain relief and satisfaction when compared with oxycodone alone.

Read the detailed description

Opiate analgesics remain the most popular option following outpatient hand surgery despite growing evidence that non-opiate analgesics may provide equivalent pain relief with fewer adverse effects and greater overall satisfaction. The purpose of this randomized trial is to compare the efficacy, side effect profiles and satisfaction associated with Ibuprofen plus Acetaminophen versus Oxycodone alone following outpatient hand surgery. No previous studies have compared the use of opiate analgesics with acetaminophen/ibuprofen following outpatient hand surgery. Patients will be randomized to receive either oxycodone alone or acetaminophen and ibuprofen following outpatient soft tissue hand surgery. Patients will be randomized to receive one of the two aforementioned pain regimens. Patients will be given a booklet in which to record pain level by visual analog scale (VAS), satisfaction with pain control, brief pain inventory and any side effects. Patients will be seen in clinic 1 week after surgery to review symptoms. Patients may also be contacted by phone to review daily log of symptoms. Patients will be seen in clinic 1 week after surgery per standard of care.

Being tested
Oxycodone Hcl 5Mg, Ibuprofen 400 mg, Acetaminophen 650 mg
Keywords
oxycodone, ibuprofen, acetaminophen, soft-tissue hand surgery, carpal tunnel release, Dupuytren contracture release, Trigger digit release, Ganglion cyst removal, De Quervain's release
Medical subject headings
Carpal Tunnel Syndrome, Dupuytren Contracture, Trigger Finger Disorder, Ganglion Cysts, De Quervain Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxycodone Hcl 5MgDrug

    Also called oxycodone

    oxycodone HCl 5 mg up to six times daily as needed for pain

  • Ibuprofen 400 mgDrug

    Ibuprofen 400 mg up to six times daily as needed for pain

  • Acetaminophen 650 mgDrug

    Acetaminophen 650 mg up to four times daily as needed for pain

Study groups in NCT03111186
Study groupRoleWhat they receive
Opiate groupActive comparatorGroup receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain)
Receives: Drug: Oxycodone Hcl 5Mg
Non-opiate groupActive comparatorGroup receiving ibuprofen and acetaminophen (acetaminophen 650 mg up to four times daily and ibuprofen 400 mg up to six times daily as need for pain)
Receives: Drug: Ibuprofen 400 mg; Drug: Acetaminophen 650 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in VAS pain scale

    Visual Analog Score - pain scale, patient questionnaire

    Measured: baseline, daily - up to 1 week postoperative

Secondary outcomes (2)

  1. change in Brief Pain Index

    Brief Pain Index - pain scale, patient questionnaire

    Measured: baseline, daily - up to 1 week postoperative

  2. change in pain diary

    Pain Diary - pain scale, patient questionnaire

    Measured: baseline, daily - up to 1 week postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start24 Apr 2017
  3. Primary completion1 May 2019
  4. Study completion1 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients of either sex, greater than 18 years of age, scheduled to undergo elective outpatient soft tissue hand surgery for one of the following procedures: carpal tunnel release, Dupuytren contracture release, trigger digit release, ganglion cyst removal, De Quervain's release, whose primary language is English or Spanish
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03111186
Sponsor's protocol ID
HS-15-00706
Status last verified
Jun 2019
First submitted
6 Apr 2017
Last updated
26 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared as required with the USC Health Sciences Institutional Review Board. Participant data will be coded with coding identifiers kept separately by research personnel only and destroyed upon completion of the study.

Publications

  • Coluzzi F, Bragazzi L, Di Bussolo E, Pizza G, Mattia C. Determinants of patient satisfaction in postoperative pain management following hand ambulatory day-surgery. Minerva Med. 2011 Jun;102(3):177-86.

    PubMed 21593720

  • Munns JJ, Awan HM. Trends in carpal tunnel surgery: an online survey of members of the American Society for Surgery of the Hand. J Hand Surg Am. 2015 Apr;40(4):767-71.e2. doi: 10.1016/j.jhsa.2014.12.046. Epub 2015 Mar 4.

    PubMed 25747738

  • Manchikanti L, Singh A. Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids. Pain Physician. 2008 Mar;11(2 Suppl):S63-88.

    PubMed 18443641

  • Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.

    PubMed 22410178

  • Nauta M, Landsmeer ML, Koren G. Codeine-acetaminophen versus nonsteroidal anti-inflammatory drugs in the treatment of post-abdominal surgery pain: a systematic review of randomized trials. Am J Surg. 2009 Aug;198(2):256-61. doi: 10.1016/j.amjsurg.2008.11.044.

    PubMed 19628064

  • Rawal N, Allvin R, Amilon A, Ohlsson T, Hallen J. Postoperative analgesia at home after ambulatory hand surgery: a controlled comparison of tramadol, metamizol, and paracetamol. Anesth Analg. 2001 Feb;92(2):347-51. doi: 10.1097/00000539-200102000-00013.

    PubMed 11159230

  • Mitchell A, van Zanten SV, Inglis K, Porter G. A randomized controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine after outpatient general surgery. J Am Coll Surg. 2008 Mar;206(3):472-9. doi: 10.1016/j.jamcollsurg.2007.09.006. Epub 2007 Nov 26.

    PubMed 18308218

  • Joris J. Efficacy of nonsteroidal antiinflammatory drugs in postoperative pain. Acta Anaesthesiol Belg. 1996;47(3):115-23.

    PubMed 8959196

  • Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.

    PubMed 20142348

  • Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.

    PubMed 11719741

  • McCartney CJ, Brull R, Chan VW, Katz J, Abbas S, Graham B, Nova H, Rawson R, Anastakis DJ, von Schroeder H. Early but no long-term benefit of regional compared with general anesthesia for ambulatory hand surgery. Anesthesiology. 2004 Aug;101(2):461-7. doi: 10.1097/00000542-200408000-00028.

    PubMed 15277930

  • Vranceanu AM, Jupiter JB, Mudgal CS, Ring D. Predictors of pain intensity and disability after minor hand surgery. J Hand Surg Am. 2010 Jun;35(6):956-60. doi: 10.1016/j.jhsa.2010.02.001. Epub 2010 Apr 9.

    PubMed 20381981

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxycodone Hcl 5Mg, Ibuprofen 400 mg and Acetaminophen 650 mg in people with Carpal Tunnel Syndrome and Dupuytren Contracture, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in VAS pain scale (time frame: baseline, daily - up to 1 week postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03111186, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.

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